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Disposable Medical Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.

Disposable Medical Mask is a single-use, three layer, flat-folded mask with ear loops and nose piece. The inner and outer layers are constructed of spun-bond polypropylene and the middle layer is constructed of melt blown polypropylene filter. The mask is held in place over the mouth and nose by two elastic loops welded to the facemask. The elastic loops are not made with natural rubber latex. The nose piece is made of malleable polyethylene with aluminum wire and allows the user to fit the facemask around their nose. Disposable Medical Mask is sold non-sterile and is intended to be a single use, disposable device.

Here's a breakdown of the acceptance criteria and study information for the "Disposable Medical Mask," based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The non-clinical testing was performed using 3 nonconsecutive lots with a total of 96 samples evaluated.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. However, given that the manufacturer is Dong Guan Kinyet Metal Products Co., Ltd. in China, it's highly probable the testing was conducted prospectively in a laboratory, potentially in China or a facility used by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable (N/A) for this type of device and study. The "ground truth" for the performance criteria of a medical mask (like filtration efficiency, fluid resistance, biocompatibility) is established through standardized laboratory test methods (e.g., ASTM, ISO standards), not through expert consensus on cases. The results are objective measurements.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is N/A for this type of device and study, as the tests are objective measurements based on standardized protocols, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is N/A. This document describes the performance of a physical medical device (a mask), not an AI-powered diagnostic or assistive technology that would involve human readers or MRMC studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is established by objective, quantitative measurements obtained through adherence to recognized international and national standards (ASTM, ISO, 21 CFR). For example:

• Fluid resistance is measured by the ability to resist penetration by synthetic blood at a certain pressure.
• Bacterial filtration efficiency is measured by the percentage of bacteria filtered.
• Biocompatibility (cytotoxicity, irritation, sensitization) is assessed through standardized in-vitro and in-vivo tests that yield measurable results (e.g., cell viability, observed reactions).

8. The Sample Size for the Training Set

This information is N/A. This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

This information is N/A as there is no training set.

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